Deforming anchor device

ABSTRACT

An anchor that secures to a connector as part of an anchor assembly is disclosed. The proximal anchor includes deformable structure for engaging a connector.

This application is a continuation-in-part of: 1) copending U.S. patentapplication Ser. No. 12/852,243, filed Aug. 6, 2010; 2) copending U.S.patent application Ser. No. 12/512,674, filed Jul. 30, 2009 which claimsthe benefit of Provisional Application Ser. No. 61/084,937; 3) copendingU.S. patent application Ser. No. 11/775,162, filed Jul. 9, 2007: 4)copending U.S. patent application Ser. No. 11/671,914, filed Feb. 6,2007; 5) copending U.S. patent application Ser. No. 11/492,690, filed onJul. 24, 2006; 6) copending U.S. patent application Ser. No. 11/833,660,filed on Aug. 3, 2007, which is a continuation of U.S. patentapplication Ser. No. 11/318,246, filed on Dec. 20, 2005; and 7)copending U.S. patent application Ser. No. 11/838,036 filed on Aug. 13,2007, which is a continuation of U.S. patent application Ser. No.11/134,870 filed on May 20, 2005; the entire disclosures of each ofwhich are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The disclosed embodiments relate generally to medical devices andmethods, and more particularly to systems and associated methods formanipulating or retracting tissues and anatomical or other structureswithin the body of human or animal subjects for the purpose of treatingdiseases or disorders.

BACKGROUND

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., glands, organs, ligaments, tendons,muscles, tumors, cysts, fat pads, and the like) within the body of ahuman or animal subject. Such procedures are often carried out for thepurpose of treating or palliating the effects of diseases or disorders(e.g., hyperplasic conditions, hypertrophic conditions, neoplasias,prolapses, herniations, stenoses, constrictions, compressions,transpositions, congenital malformations, and the like) and/or forcosmetic purposes (e.g., face lifts, breast lifts, brow lifts, and thelike) and/or for research and development purposes (e.g., to createanimal models that mimic various pathological conditions). In many ofthese procedures, surgical incisions are made in the body, and laborioussurgical dissection is performed to access and expose the affectedtissues or anatomical structures. Thereafter, in some cases, theaffected tissues or anatomical structures are removed or excised. Inother cases, various natural or man-made materials are used to lift,sling, reposition or compress the affected tissues.

Benign Prostatic Hyperplasia (BPH):

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffects men, especially elderly men. It has been reported that, in theUnited States, more than half of all men have histopathologic evidenceof BPH by age 60 and, by age 85, approximately 9 out of 10 men sufferfrom the condition. Moreover, the incidence and prevalence of BPH isexpected to increase as the average age of the population increases indeveloped countries.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus, the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate, and the like.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine, and the like)that cause urinary retention especially in men with prostateenlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1 a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1 a-adrenergic receptors blockersblock the activity of alpha-1 a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1 a-adrenergic receptorscauses prostatic smooth muscle relaxation. This, in turn, reducesurethral resistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todi-hydro-testosterone. Di-hydro-testosterone causes growth of epithelialcells in the prostate gland. Thus, 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and, hence, reducethe volume of the prostate gland, which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethalResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethal Resection of Prostate (TURP) is the most commonly practicedsurgical procedure implemented for the treatment of BPH. In thisprocedure, prostatic urethral obstruction is reduced by removing most ofthe prostatic urethra and a sizeable volume of the surrounding prostategland. This is carried out under general or spinal anesthesia. In thisprocedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus, the region of the urethra that isblocked by the surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam, and the like.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, a neodymium:Yttrium-aluminum-garnet (NdYAG) laser is used to ablate tissue bycausing coagulation necrosis. The procedure is performed under visualguidance. In HoLEP, a holmium: Yttrium-aluminum-garnet laser is used fordirect contact ablation of tissue. Both these techniques are used toremove tissue obstructing the urethral passage to reduce the severity ofBPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand, hence, is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate gland,thus, reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat-induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser-induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra, and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland, and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser-induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which, in turn, causes the prostate glandto shrink. Shrinkage of the prostate gland reduces the degree ofsqueezing of the urethra by the prostate, thus, reducing the severity ofBPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1 a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only have a modest effect on BPH symptoms and the flow rate ofurine. In addition, anti-androgens, such as 5-alpha-reductase, requiremonths of therapy before LUTS improvements are observed. Surgicaltreatments of BPH carry a risk of complications including erectiledysfunction; retrograde ejaculation; urinary incontinence; complicationsrelated to anesthesia; damage to the penis or urethra; need for a repeatsurgery; and the like. Even TURP, which is the gold standard intreatment of BPH, carries a high risk of complications. Adverse eventsassociated with this procedure are reported to include retrogradeejaculation (65% of patients), post-operative irritation (15%), erectiledysfunction (10%), need for transfusion (8%), bladder neck constriction(7%), infection (6%), significant hematuria (6%), acute urinaryretention (5%), need for secondary procedure (5%), and incontinence(3%). Typical recovery from TURP involves several days of inpatienthospital treatment with an indwelling urethral catheter, followed byseveral weeks in which obstructive symptoms are relieved, but there ispain or discomfort during micturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries has made their removal quite difficult andinvasive.

Thus, the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and, in fact, often experiencesworse symptoms for weeks after the procedure until the body begins toheal. Additionally, all device approaches require a urethral catheterplaced in the bladder, and in some cases for weeks. In some cases,catheterization is indicated because the therapy actually causesobstruction during a period of time post operatively, and in other casesit is indicated because of post-operative bleeding and potentiallyocclusive clot formation. While drug therapies are easy to administer,the results are suboptimal, take significant time to take effect, andoften entail undesired side effects.

Cosmetic or Reconstructive Tissue Lifting and Repositioning:

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts, or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, and the like,have become commonplace. In many cases, these procedures are performedby creating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin, and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, or other muscles) to hold the repositionedtissues in their new (e.g., lifted) position. In some cases, excess skinmay also be removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,connector suspension lifts have been developed where one end of astandard or modified connector thread is attached to muscle and theother end is anchored to bone, periostium or another structure to liftand reposition the tissues as desired. Some of these connectorsuspension techniques have been performed through cannulas or needlesinserted though relatively small incisions of puncture wounds.

There remains a need for the development of a suture lock or a sutureanchor for use in various contemplated applications. In particular,there is a need for an anchor which can be deformed to lockingly engagesuture once access to an interventional site is achieved. The disclosedembodiments address these and other needs.

SUMMARY

Briefly and in general terms, the disclosed embodiments are directedtowards an anchor assembly for use within a patient's body. In oneembodiment, an anchor secures to a connector in the form of a suture.The structures can further form an assembly including a distal anchorconnected to a proximal anchor.

In various approaches, the anchor can include a solid generallycylindrical or alternatively a tubular back end. The anchor can alsoinclude a pair of spaced members which are configured to capture anddeform the suture there between and prevent the suture from disengagingfrom the anchor device once engaged. Alternatively, portions of atubular anchor body are deformable about the suture. The mechanism ofsuture attachment and strength of the assembly is a combination ofcompression of the suture between deformable structure of the anchor aswell as disruption of the suture surface by the anchor. The deformablestructure provides surface contact and focuses the compressive forcesthat cause the suture to conform about the anchor.

In one specific approach, the anchor includes legs which are deformedabout a connector. In one approach, the legs assume a first openconfiguration and are deformed to define a closed configuration. Thelegs can be laterally or longitudinally deformed in various contemplatedembodiments. In another approach, the anchor includes a mid-sectiondefining a through hole and first and second ends which are twisted withrespect to each other to close the hole about a connector.

In other aspects, the anchor can include a pair of spaced prongs joinedtogether at a slot inception. Distal ends of the prongs are deformableto close the anchor about a connector. In yet another approach, theanchor can be formed by a single continuous wall defining a slot foraccepting a connector. Lateral portions of the wall are deformableinwardly to securely engage the connector.

Other features and advantages will become apparent from the followingdetailed description, taken in conjunction with the accompanyingdrawings, which illustrate by way of example, the features of thevarious embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of an anchor assemblythat includes a distal anchor and a proximal anchor secured together bya suture;

FIGS. 2A-D are side views, depicting one embodiment of a deformableanchor assembly and structure for deforming the anchor;

FIGS. 3A-C are side views and a perspective view, depicting anotherembodiment of a deformable anchor assembly and structure for deformingthe anchor;

FIGS. 4A-B are side views of yet another embodiment of a deformableanchor assembly;

FIG. 5 is a schematic representation, depicting one alternate approachto the anchor of FIGS. 4A-B;

FIG. 6 is a schematic representation, depicting another approach to theanchor assembly of FIGS. 4A-B;

FIGS. 7A-B are perspective views, depicting a longitudinal collapsibleanchor;

FIGS. 8A-B are perspective views, depicting a still further approach toa deformable anchor;

FIGS. 9A-B are schematic representations, highlighting features of theanchor of FIGS. 7A-B;

FIGS. 10A-C include a perspective view and side views, depicting afurther approach to a deformable anchor;

FIGS. 11A-C are perspective views, depicting yet a further approach to adeformable anchor;

FIGS. 12A-B are still yet another deformable side view, depicting adeformable anchor with deformable walls;

FIG. 13 is a side view of a deformable anchor with a orthogonallyoriented tail portion;

FIG. 14 is a side view of the distal anchor with a orthogonally orientedtail portion of FIG. 14 attached to a connector; and

FIGS. 15A-F are partial cross sectional views of an anchor assembly ofFIG. 1 being implanted through the prostate of an individual with BenignProstatic Hyperplasia.

DETAILED DESCRIPTION

Turning now to the figures, which are provided by way of example and notlimitation, the disclosed embodiments are embodied in anchor assembliesconfigured to be delivered within a patient's body. As stated, thedisclosed embodiments can be employed for various medical purposesincluding but not limited to retracting, lifting, compressing,supporting or repositioning tissues, organs, anatomical structures,grafts or other material found within a patient's body. Such tissuemanipulation is intended to facilitate the treatment of diseases ordisorders. Moreover, the disclosed embodiments have applications incosmetic or reconstruction purposes, or in areas relating to thedevelopment or research of medical treatments. Referring now to thedrawings, wherein like reference numerals denote like or correspondingcomponents throughout the drawings and, more particularly to FIGS. 1-15,there are shown aspects of an anchor assembly.

In such applications, one portion of an anchor assembly is positionedand implanted against a first section of anatomy. A second portion ofthe anchor assembly is then positioned and implanted adjacent to asecond section of anatomy for the purpose of retracting, lifting,compressing, supporting or repositioning the second section of anatomywith respect to the first section of anatomy, as well as for the purposeof retracting, lifting, compressing, supporting or repositioning thefirst section of anatomy with respect to the second section of anatomy.It is also to be recognized that both a first and second portion of theanchor assembly can be configured to accomplish the desired retracting,lifting, compressing, supporting or repositioning of anatomy due totension supplied thereto via a connector assembly (e.g., suture) affixedto the first and second portions of the anchor assembly.

Certain of the contemplated approaches involve proximal anchors whichare placed about a connector prior to its deformation and connection tothe connector which thus can eliminate a risk of the proximal anchor notcatching the connector. Certain approaches also can involve slow andcontrolled deformation which can lead to a desirable engagement betweenthe anchor and connector. Further, steps can be taken to strengthen thelock between anchor and connector such as by cold working the anchormaterial during or after deformation.

In one embodiment of the anchor assembly, the anchor assembly isconfigured to include structure that is capable of being implantedwithin a patient's body. The anchor assembly may also be used inconjunction with a conventional remote viewing device (e.g., anendoscope) so that an interventional site can be observed.

In one embodiment, the anchor assembly can be placed at an interventionsite using a delivery tool. One specific, non-limiting application ofthe delivery tool is for the treatment of benign prostatic hyperplasia.In this procedure, an implant is delivered to a prostatic lobe that isobstructing the urethral opening and restricting flow. The implantcompresses the lobe, thereby increasing the urethral opening andreducing the fluid obstruction through the prostatic urethra.

Additionally, in one embodiment, the anchor assembly is embodied in atissue approximation anchor (TAA). The tissue approximation anchor is animplant assembly that includes one tubular member (preferably comprisedof Nitinol or other comparable material), referred to as the capsularanchor or, more generally, distal anchor 70. The distal anchor 70 ispreferably connected by a suture 78 to a slotted, flattened-tubularmember (preferably comprised of stainless steel), referred to as theurethral anchor or proximal anchor 84. In one specific, non-limitingembodiment, the distal anchor 70 is comprised of an electro-polishedNitinol (nickel titanium alloy SE508, 55.8% nickel) tube.

The tissue approximation anchor is designed to be useable in an officeenvironment (in contrast to requiring a hospital environment). Thedelivery tool is used through a 19Fr introducer sheath size in onepreferred embodiment, while in another embodiment a sheath size of 21 Fis employed. Additionally, the material selection and construction ofthe tissue approximation anchor still allows for a subsequent TURPprocedure to be performed, if necessary. In this suture-based, tissueapproximation technique, a needle delivery mechanism is used to implanta nitinol distal anchor 70 and attached connector or suture 78. In oneapproach, the introducer sheath is first placed within a patient'surethra. An anchor housed within the delivery tool is then placedthrough the introducer sheath and a distal portion of the delivery toolis placed at the interventional site. Once the distal anchor 70 andattached suture 78 have been deployed, with the needle retracted and thesuture 78 tensioned, the anchor 84 is pushed by the delivery tool andcaptures the suture 78 transverse to the anchor axis.

In one embodiment, the nitinol tube is attached to a USP size 0 PET(Poly Ethylene Terephthalate) monofilament suture 78 by thermallyforming the suture to locking features on the distal anchor 70 (See FIG.1). Referring again to the suture itself, the PET suture is a roundmonofilament extrusion/pulltrusion composed of a grade 8816 polyethyleneterephthalate. Typically, the base material for the suture is annealedat approximately 191 degrees Celsius for approximately 5 minutes in astraight condition. In one non-limiting embodiment, the PET suture 78has a diameter of 0.015 inches and a tensile strength greater than orequal to 6.0 pounds.

In one embodiment, as shown in FIGS. 2A-D, the anchor 84 includes aproximal end 86 defined by a cylinder and a distal end portion 88 thatcan assume both open and closed positions. The distal end 88 includes apair of arms 90, which are bent at their mid-points and connected atdistal terminal ends thereof. An anchor delivery device can include atranslatable sleeve 91 which can be moved relative to the anchor 83 todeform the arms 9Q so that they assume a straightened configuration.When straightened, the arms 90 grip and deform the connector 78configured therebetween. The interior structure of the arms 90 functionto disrupt the surface of the connector 78, both biting into theconnector 78 as well as compressing the suture 78. The anchor 84 canfurther include a slot inception 92 for registering and receiving theconnector 78. Deforming the arms 90 to a closed position captures theconnector 78 within the slot inception 92.

Notably, in one embodiment the anchor 84 is dimensionally relative tothe diameter of the suture 78 such that is has sufficient gripping forceto obviate the need for a securing end unit. Accordingly, in a preferredembodiment, a second or supplemental structure is not needed.

In one embodiment, shaped tube raw stock is used to produce the anchor84 using slot/profile cutting. Specifically, in one embodiment the rawstock may be cut by laser, wire-EDM, or stamped from a flat and formedinto a shape. In one non-limiting embodiment, the raw stock has a totalheight ranging from 0.020 inches to 0.025 inches, and has a total widthranging from 0.038 inches to 0.042 inches. Thus, this raw stock isflatter and wider than a purely round tube would be.

The inwardly facing structure of the arms 90 of the anchor 84 isconfigured to grasp and deform the suture 78. It will be appreciated bythose skilled in the art, that many variations such structure arepossible for optimizing performance in different situations.Additionally, in some embodiments, the protrusions formed on oppositeprongs may be of differing shapes. Such slot parameters include, by wayof example only, and not by way of limitation: width, thickness, length,and profile. Optionally, the anchor assembly may be filled in with an ROmaterial, or other therapeutic agent.

With reference to FIGS. 3A-C, in another embodiment, a proximal anchor100 can be defined by proximal 102 and distal 104 tabs joined togetherat a center circular structure 106 with a hole 108 formed therethrough.The center circular structure 106 is contemplated to define deformablestructure for capturing a connector. In use, a connector 78 can bethreaded through the center hole 108. A delivery device can include alongitudinally rotatable arm 110 with a slot 112 formed in a distal endthereof. The slot 112 is sized and shaped to receive the proximal tab102. The delivery device can further include a stabilizing block 114configured to retain the distal tab 104.

To securely attach a connector 78 to the proximal anchor 100, the arm112 is rotated so that the proximal tab 102 is in turn rotated withrespect to the distal tab 104. This action results in twisting thedeformable members defining the center circular structure 106 about aconnector 78 threaded therethrough. In this way, the anchor 100 can besecurely fixed to the connector. It should be recognized that thedeformable structure of this embodiment can assume a myriad of otherconfigurations that can be twisted about a connector.

As shown in FIGS. 4A-6, the proximal anchor 120 can also includelongitudinally collapsible structure. In this embodiment, an anchordelivery apparatus (not shown) would include a driving member and astop, between which the longitudinally collapsible anchor 120 can bedeformed. Thus, the collapsible anchor 120 can include a proximal end122 attached to a distal end 124 by a central collapsible framework 126.The collapsible framework 124 can further be defined by a pair of spacedarms 128 which initially includes bends 130. Longitudinal compression ofthe anchor 120 causes the arms 128 to collapse such that a first sectionof the arms 128 fold over a second section of the arms 128.

As best seen in FIGS. 5 and 6, the arms 128 of the collapsible anchor120 can have various configurations. That is, in a first approach (FIG.5), a first section 132 of the collapsible arms 128 can have a longerlength than a second section 134. In other approaches, the arms 128 canhave sections 132, 134 having other relative lengths. For example, asshown in FIG. 6, the sections 132, 134 can be approximately the samelength. Thus, the collapsible nature of the anchor can be adjusted for aparticular purpose so that a connector 78 can be best fixed to thecollapsible anchor 120.

Another approach to a longitudinally collapsible anchor 140 is shown inFIGS. 7A-B. Here, a midsection of the anchor 140 includes a series oflongitudinally extending slots 142. Members 144 configured between theslots 142 are designed to deform outwardly in response to forces whichlongitudinally collapse the anchor 140. Such projections 146 canpotentially aid in fixing the anchor 140 at an interventional site.

Turning now to FIGS. 8A-B and 9A-B, additional aspects of a proximalanchor 160 are presented. In this approach, the anchor 160 is defined bya solid bar or tube with a central opening 162 that can be closed whenopposing forces are placed on ends of the anchor 160. The centralopening 162 can alternatively be closed about a connector (not shown) byconvexly curved arms 164 defining the opening 162. Thus, it iscontemplated that an anchor delivery apparatus can include an extendedarm or sleeve 166 that engages the curved arms 164 to translate aportion 168 thereof against a connector to form a secure attachment. Thedeformed arms 164 resists opening until a force greater than expectedthat a connector can provide is applied to the device.

Other contemplated deformable anchors 180 can assume a pin including apair of spaced, deformable arms 182 (See FIGS. 10A-C and 11A-C). Inthese embodiments, the arms 182 define a slot for receiving and securelyaffixing to a connector 98. The arms 182 can be deformed in variousways. In a first approach, an anchor delivery apparatus can include asleeve 186 including a pair of internally directed projections 186 forclosing and deforming the legs 182 about a connector 78. Distal terminalends 186 of the legs 182 are permitted to flare away from each other. Asshown in FIGS. 11A-C, a deforming sleeve can further include formingstructure which guides the distal terminal ends 182 of the arms to aclosed position to eliminate the flares.

In yet another aspect, the deformable anchor 200 can include a singlecontinuous wall 202 defining a perimeter of the anchor. An internalportion 204 of the anchor 200 is an open space. The wall 202 includes apair of curved laterally extending structures 206 which presentdeformable structure. The wall 202 also defines a slot 208 for receivinga connector 78.

To attach the anchor 200 to a connector 78, it is contemplated thatinwardly directed forces be applied to the laterally extendingstructures 206. In one approach, the anchor 200 can be advanced througha delivery apparatus including a narrowed section 210 which engages thelateral walls 206 and deforms them inwardly about the connector. Suchaction reduces the slot to thereby facilitate the walls gripping theconnector.

With each of the above described embodiments, a locking engagement witha connector 78 is achieved with a deforming anchor. Again, deformationof the anchor into locking engagement can be accomplished in variousconventional approaches, such as including structure that transmits aforce in lateral and longitudinal directions.

One embodiment of a distal anchor assembly 70 is depicted in FIGS. 13and 14. In its unconstrained configuration, the distal (e.g., capsular)anchor 70 includes a tubular (head) portion 72 which is generallyorthogonally oriented to a tail portion 74. It is to be noted, however,that while housed in a delivery assembly and prior to deployment at atarget area, the distal anchor 70 is constrained to define a generallystraight configuration, only subsequently assuming the unconstrained(i.e., orthogonally oriented) configuration upon deployment from adelivery device.

The distal anchor 70 is laser cut or wire EDM (electrical dischargemachined) from a nitinol base stock that is generally-tubular is shape.The Nitinol distal anchor is shape-set to have a “flipping tail” and iselectro-polished. The connector 78 is then attached to the distal anchor70 as an adhesive free joint. Specifically, in one embodiment, the PETsuture 78 is thermoformed onto locking features in the anchor 70. Thedistal anchor 70 may be locally heated to re-flow the suture onto theend of the anchor 70 and into cutouts on the anchor 70. Continuing, inone non-limiting embodiment, the post electro-polished distal anchor 70has a 0.016 inner diameter and a 0.0253 outer diameter.

In one non-limiting embodiment, the tubular portion 72 of the distalanchor 70 includes a plurality of tabs 76 which can be deformed ordeflected to accomplish affixing the distal anchor 70 to a suture 78. Ithas been found that three such tabs 76, two on one side of the tubularportion 72 and one on an opposite side, provide a sufficient connectingforce and a desired balance between the suture 78 and distal anchor 70and to move the distal anchor 70 by applying a force either in theproximal or distal direction. However, the distal anchor 70 may beattached to the suture 78 through any of several known techniques, suchas by being attached to the distal end of the tubular portion 72.

In another aspect of a non-limiting embodiment, t is contemplated thatthe distal anchor 70 can be laser cut from a tube formed of Nitinol orother appropriate material. A mid-section 80 of the distal anchor 70provides a structural transition from the tubular portion 72 to the tailportion 74. As such, a portion of a side wall is removed in themid-section area 80. A further portion of the side wall is removed todefine a connector section 82 of the tail 74 which extends from themid-section 80. In one embodiment, this connector section 82 includes abend that creates the orthogonally oriented configuration. Thisconnector section 82 acts as a barb or deflected strut to cause flipping(creating a “flipping tail”) and produce the relative unconstrained(orthogonally oriented) angle assumed between the tail 74 and tubularportion 72 of the distal anchor 70. The recovered shape of the terminalend portion 83 of the anchor presents a transverse strut that engagestissue when the suture is tensioned.

Thus, in its pre-implanted form, the anchor assembly can include adistal anchor 70 (e.g., first anchor) whose initial engagement with asuture 78 is generally coaxial, and a proximal anchor 84 (e.g., secondanchor) with an initial engagement being generally perpendicular withthe suture 78.

As stated above, an introducer sheath (not shown) can first be placedwithin a patient's urethra for the purpose of facilitating access to atreatment site. The distal anchor 70 is “unsheathed” from the needledelivery mechanism once positioned for reliable deployment eliminatingpredicate distal suture. This results in an adjustable implant length.This distal anchor 70 configuration also provides increased yield andstrength.

With reference now to FIGS. 15A-F, in one particular, non-limiting usein treating a prostate, an elongate tissue access portion 404 of adelivery device 400 is placed within a urethra (UT) leading to a urinarybladder (UB) of a patient. The delivery device can be placed within anintroducer sheath previously positioned in the urethra or alternatively,the delivery device can be inserted directly within the urethra. Thepatient is positioned in lithotomy. The elongate portion 404 is advancedwithin the patient until a leading end 410 thereof reaches a prostategland (PG). In a specific approach, the side(s) (i.e., lobe(s)) of theprostate to be treated is chosen while the device extends through thebladder and the device is turned accordingly. The device is firstpositioned at the bladder neck and then retracted approximately 1 cmwhile keeping the device parallel to the prostatic fossa and preservingmucosa. The distal end of the elongate portion can be used to push theurethra into the prostate gland. The inside of the prostate gland (i.e.,adenoma) is spongy and compressible and the outer surface (i.e.,capsule) of the prostate gland is firm. By the physician viewing withthe endoscope, he/she can push the urethra into the prostate glandcompressing the adenoma and creating the desired opening through theurethra. To accomplish this, the physician pivots the tool laterallyabout the pubic symphysis, generally about 20 to 30 degrees (See FIG.15A). The physician then rotates the tool anterior between 9 and 10o'clock for the patient's side right lobe and between 2 and 3 o'clockfor the patient's side left lobe. Viewing through the endoscope, thephysician wants to have about the same amount of tissue protruding onboth sides of the elongate shaft (See FIG. 15B).

At the leading end 410 of the delivery device, as shown in FIG. 15C, aneedle 430 carrying an anchor assembly is ejected into and throughtissue. The needle assembly can be configured so that it curves backtoward the delivery tool as it is ejected. In use in a prostateintervention, the needle assembly 430 is advanced through and beyond aprostate gland (PG). The delivery device can be rotated anteriorly tolift a prostatic lobe.

Upon withdrawal of the needle assembly 430 (See FIG. 15D), the distalanchor 20 is left beyond the prostate (PG). Next, steps are taken toimplant the proximal anchor 84 within the urethra (FIG. 15E). Either asingle anchor assembly or multiple anchor assemblies can be deliveredand deployed at an intervention site by the deployment device (See FIG.15F). Additionally, a single anchor assembly component can for example,be placed on one side of a prostate or urethra while multiple anchorassembly components can be positioned along an opposite or displacedposition of such anatomy. The number and locations of the anchorassemblies can thus be equal and/or symmetrical, different in number andasymmetrical, or simply asymmetrically placed. In the context ofprostate treatment, the present invention is used for the compression ofthe prostate gland and the opening of the prostatic urethra, thedelivering of an implant at the interventional site, and applyingtension between ends of the implant. Moreover, drug delivery is bothcontemplated and described as a further remedy in BPH and over activebladder treatment as well as treating prostate cancer and prostatitis.

The disclosed embodiments contemplate both pushing directly on anchorportions of an anchor assembly as well as pushing directly upon theconnector of the anchor assembly. Further, an anchor assembly can bedelivered and deployed at an interventional site by a deployment device.Consequently, in the context of prostate treatment, the disclosedembodiments accomplish both compressing of the prostate gland and theopening of the prostatic urethra and applying tension between ends ofthe implant. Moreover, drug delivery is contemplated as a further remedyin BPH and over-active bladder treatment.

Once implanted, the anchor assembly of the disclosed embodimentsaccomplishes desired tissue approximation, manipulation, compression orretraction, as well as cooperates with the target anatomy to provide anatraumatic support structure. In particular, the shape and contour ofthe anchor assembly can be configured so that the assembly invaginateswithin target tissue, such as within natural folds formed in the urethraby the opening of the urethra lumen by the anchor assembly. In fact, insituations where the anchor assembly is properly placed, wispy orpillowy tissue in the area collapses around the anchor structure.Eventually, the natural tissue can grow over the anchor assembly, andnew cell growth occurs over time. Such cooperation with target tissuefacilitates healing and avoids unwanted side effects such ascalcification or infection at the interventional site.

Furthermore, in addition to an intention to cooperate with naturaltissue anatomy, the disclosed embodiments also contemplate approaches toaccelerate healing or induce scarring. Manners in which healing can bepromoted can include employing abrasive materials, textured connectors,biologics and drugs.

It has been observed that placing the anchors at various desiredpositions within the anatomy can extract the best results. For example,when treating a prostate, one portion of an anchor can be placed withina urethra. It has been found that configuring such anchors so that teno'clock and two o'clock positions (when looking along the axis of theurethra) are supported or retained, effectively holds the anatomy openand also can facilitate invagination of the anchor portion withinnatural tissue. Typically, one to two pairs of anchor assemblies areimplanted to create an anterior channel along the urethra within theprostate gland (FIG. 15F). This is particularly true in the regions ofanatomy near the bladder and the juncture at which the ejaculatory ductconnects to the urethra.

Moreover, it is to be recognized that the foregoing procedure isreversible. In one approach, the connection of an anchor assembly can besevered and a proximal (or second) anchor component removed from thepatient's body. For example, the physician can simply cut the connectorand simultaneously remove the second anchor previously implanted forexample, in the patient's urethra. It is to be recognized that variousmaterials are contemplated for manufacturing the disclosed devices.Moreover, one or more components such as distal anchor 70, proximalanchor 84, suture 78, of the one or more anchor assemblies disclosedherein may be designed to be completely or partially biodegradable orbio-fragmentable.

Further, as stated, the systems and methods disclosed herein may be usedto treat a variety of pathologies in a variety of tubular structurescomprising a cavity or a wall. Examples of such organs include, but arenot limited to urethra, bowel, stomach, esophagus, trachea, bronchii,bronchial passageways, veins (e.g. for treating varicose veins orvalvular insufficiency), arteries, lymphatic vessels, ureters, bladder,cardiac atria or ventricles, uterus, fallopian tubes, and the like.

Finally, it is to be appreciated that the invention has been describedhereabove with reference to certain examples or embodiments, but thatvarious additions, deletions, alterations and modifications may be madeto those examples and embodiments without departing from the intendedspirit and scope of the disclosed embodiments. For example, any elementor attribute of one embodiment or example may be incorporated into orused with another embodiment or example, unless to do so would renderthe embodiment or example unpatentable or unsuitable for its intendeduse. Also, for example, where the steps of a method are described orlisted in a particular order, the order of such steps may be changedunless to do so would render the method unpatentable or unsuitable forits intended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

The various embodiments described above are provided by way ofillustration only and should not be construed to limit the disclosedembodiments. Those skilled in the art will readily recognize variousmodifications and changes that may be made to the disclosed embodimentswithout following the example embodiments and applications illustratedand described herein, and without departing from the true spirit andscope of the disclosed embodiments, which is set forth in the followingclaims.

1. An anchor assembly for use in treating body tissue, comprising: adistal anchor; a connector; and a proximal anchor, the proximal anchorincluding a deformable portion and a non-deformable portion spacedlongitudinally from the deformable portion, the deformable portionincluding a space defined by spaced legs with connected terminal endsand sized to receive the connector; wherein legs are configured tocollapse inwardly in part or completely to capture and deform theconnector therebetween.
 2. The anchor assembly of claim 1, wherein thelegs can assume an open position and a closed position.
 3. The anchorassembly of claim 1, wherein the anchor further including a slotinception.
 4. The anchor assembly of claim 2, wherein the legs include abend positioned at a mid-section of the legs.
 5. The anchor assembly ofclaim 1, distal anchor comprising a laterally oriented tail.
 6. Theanchor assembly of claim 5, the distal anchor further comprising atubular portion which is generally perpendicular to a tail portion. 7.The anchor assembly of claim 6, wherein the tubular portion includestabs for affixing the distal anchor to the connector.
 8. A system fortreating body tissue, comprising: a distal anchor, a connector, aproximal anchor, the proximal anchor including a deformable portionconfigured between a first tab and a second tab, the deformable portionincluding a space sized to receive the connector, wherein the first tabis rotatable with respect to the second tab; and a delivery apparatusincluding a rotatable member that receives the first tab and astabilizing member receiving the second tab, wherein the rotatablemember turns the first tab with respect to the second tab to therebyclose the deformable portion about the connector.
 9. The system of claim8, wherein the deformable portion is twisted as the rotatable member isrotated.
 10. The system of claim 1, distal anchor comprising a laterallyoriented tail.
 11. The system of claim 5, the distal anchor furthercomprising a tubular portion which is generally perpendicular to a tailportion.
 12. The system of claim 6, wherein the tubular portion includestabs for affixing the distal anchor to the connector.
 13. An anchorassembly, comprising: a distal anchor; a connector; and a proximalanchor, the proximal anchor including a deformable portion, thedeformable portion being defined by longitudinally collapsiblestructure, and a non-deformable portion spaced longitudinally from thedeformable portion, the deformable portion including a closed spacedefined by spaced legs sized to receive the connector; wherein legs areconfigured to collapse about the non-deformable portion to capture anddeform the connector therebetween.
 14. The anchor assembly of claim 13,wherein the legs include a bend.
 15. The anchor assembly of claim 14,wherein the bend is at a midpoint of the legs.
 16. The anchor assemblyof claim 14, further comprising a first non-deformable portion and asecond non-deformable portion, wherein the deformable portion isconfigured between the first and second non-deformable portions.
 17. Theanchor assembly of claim 16, wherein the legs include a bend positionedcloser to the first non-deformable portion than the secondnon-deformable portion.
 18. An anchor assembly, comprising: a distalanchor; a connector; and a proximal anchor having a longitudinaldimension, the proximal anchor including a deformable portion, thedeformable portion being defined by longitudinally collapsiblestructure, and a non-deformable portion spaced longitudinally from thedeformable portion, the deformable portion including a space defined byspaced legs sized to receive the connector; wherein legs are configuredto bend out of the longitudinal dimension to capture and deform theconnector therebetween.
 19. The anchor assembly of claim 18, thedeformable portion further including a plurality of slots defined byradially spaced longitudinal members.
 20. The anchor assembly of claim19, wherein the radially spaced members project laterally outward whenthe assembly is deformed longitudinally.
 21. An anchoring system for usein treating body tissue, comprising: a distal anchor; a connector; and aproximal anchor, the proximal anchor including a deformable portion anda non-deformable portion spaced longitudinally from the deformableportion, the deformable portion including a space defined by spaced legswith spaced terminal ends and sized to receive the connector; whereinlegs are configured to collapse inwardly so that the legs engage eachother to capture and deform the connector therebetween.
 22. Theanchoring system of claim 21, further comprising a delivery apparatusincluding a sleeve.
 23. The anchoring system of claim 22, wherein a gapbetween a proximal portion of the legs remains after the sleeve deformsthe legs, the gap sized to fix and retain the connector.
 24. Theanchoring system of claim 23, wherein terminal ends of the legs aredeformed to be in contact and parallel.
 25. The anchoring system ofclaim 21, wherein the anchor is defined by a single continuous walldefining a perimeter about a central opening and lateral portionscompressible by the sleeve.
 26. An anchor assembly for use in treatingbody tissue, comprising: a distal anchor; a connector; and proximalanchor means for attaching to the connector, the proximal anchor meansincluding a deformable portion and a non-deformable portion spacedlongitudinally from the deformable portion, the deformable portionincluding a closed space defined by spaced legs with connected terminalends and sized to receive the connector, wherein legs are configured tocollapse inwardly to define straightened members to capture and deformthe connector therebetween.
 27. An anchor assembly, comprising: a distalanchor; a connector; and proximal anchor means for attaching to theconnector, the proximal anchor means including a deformable portion, thedeformable portion being defined by longitudinally collapsiblestructure, and a non-deformable portion spaced longitudinally from thedeformable portion, the deformable portion including a closed spacedefined by spaced legs sized to receive the connector, wherein legs areconfigured to collapse about the non-deformable portion to capture anddeform the connector therebetween.
 28. An anchor assembly, comprising: adistal anchor; a connector; and proximal anchor means for attaching tothe connector and having a longitudinal dimension, the proximal anchorincluding a deformable portion, the deformable portion being defined bylongitudinally collapsible structure, and a non-deformable portionspaced longitudinally from the deformable portion, the deformableportion including a closed space defined by spaced legs sized to receivethe connector, wherein legs are configured to bend generallyperpendicular to the longitudinal dimension to capture and deform theconnector therebetween.
 29. An anchoring system for use in treating bodytissue, comprising: a distal anchor; a connector; and proximal anchormeans for attaching to the connector, the proximal anchor meansincluding a deformable portion and a non-deformable portion spacedlongitudinally from the deformable portion, the deformable portionincluding a closed space defined by spaced legs with spaced terminalends and sized to receive the connector, wherein legs are configured tocollapse inwardly so that the legs engage each other to capture anddeform the connector therebetween.